Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Recalled by BALT USA, LLC Due to Products were released to customers prior to the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BALT USA, LLC directly.
Affected Products
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Quantity: 4 devices
Why Was This Recalled?
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Where Was This Sold?
This product was distributed to 2 states: AZ, FL
About BALT USA, LLC
BALT USA, LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report